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Course Introduction
Welcome
We QI is very glade to introduce this 5
days Lead Auditor Training Course. QI is
one of the leading & fast growing
Consultation & Training bodies in Egypt.
QI operates as a Consultation & Training
Body organized according to NQI and
International ISO 17024:2016 in Egypt
and across the globe.
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Introduction About QI
• QI is the Quality Institution for Engineering and Management
Consultancy
• Established on 2012 , fast growing Egyptian Consultation and
training firm
• Long term Partnership with Famous organizations such as:
– R&R IRCA partner
– PECB IAS accredited organization for ISO 17024
• Conduct training and Consultation on many management
systems.
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QI Clients
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Training
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Training
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Training
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Learning Objectives
Briefly describe what students will know and be able to
do by the end of the course.
On completion successful students will have the
knowledge and skills to:
Course Assessment
• Course Assessment
The outputs of the exercises are a part of the formal continuous assessment and will
therefore be marked. In order to pass the course a delegate must pass the continual
assessment and the written examination as well.
• Continual Assessment
Delegates will be assessed throughout the course. The outputs of the exercises are a
part of the formal continual assessment and will therefore be marked. Although the
exercises are group exercises individual score to the delegate will be based on their
overall participation, involvement in the relevant chapter presentation and in the
exercise.
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Final Exam
Delegates will have to write the written examination on Day 5 of the
course. A total of 2 hours will be available for the Examination.
There are 4 sections to the exam:
Section 1 (10 marks)
Section 2 (20 marks)
Section 3 (30 marks)
Section 4 (40 marks)
The pass mark is 70% and delegates are expected to achieve at least
50% in each section.
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Complaints
• All delegates have the right to make a complaint or an appeal. The delegates
will be provided with the process for the same upon request.
• QMS Standard
The delegates will be provided with the copies of AS 9100 D:2016 standard for
reference during the course.
• Delegates Introduction
IAQG Governance
The IAQG General Assembly sets the
policy, purpose and objectives of the
organization and drives initiatives to
meet the goals and objectives of the
organization. There are twenty-seven
Full Members:
Ten from the Americas
Ten from Europe
Seven from Asia-Pacific
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Sponsors
The IAQG is sponsored by three existing bodies
Europe (ASD)
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AS 9100
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AS9100 BENEFITS
• AS 9100 is an international group effort with a goal of standardizing a Quality
Management System implementation specific to the Aerospace Industry. When a
company is certified to the AS 9100 standard, they can expect these benefits:
AS 9100 improve your internal processes to maintain high-end quality and achieve
customer expectations
• Implementing the AS9100 standard requires that business processes are
monitored to improve efficiency, make continual improvements and improve
productivity
• Ensure product safety and reliability
• Improve the balance sheet and profitability
• Enhance global marketability
• Standardizes on one audit body and eliminates multiple assessments in the
aviation industry
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INTRODUCTION TO AUDITING
1. What is Audit?
INTRODUCTION TO AUDITING
Type of Audits
2. Internal or First Party Audit
INTRODUCTION TO AUDITING
• 3. External or Second Party Audit
• The Second party audit is generally known as the vendor quality assurance audit
• Objectives
1. Qualification of vendors
2. Customer’s requirement shall audit their vendors
3. Improve their quality system
4. Resolve quality problems / issues
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INTRODUCTION TO AUDITING
• 4. External Third Party Audit
• Third party audits are conducted by
an independent body (certification
body) and can either be voluntary,
as in the case of a certification
audit, or compulsory, as required
by laws and regulations.
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INTRODUCTION TO AUDITING
• 5. Stage 1 Audit
• 6. Stage 2 Audit
INTRODUCTION TO AUDITING
• 7. Follow-up Audit
• 8. Re-Certification Audit
INTRODUCTION TO AUDITING
• 9. Additional Audits
An additional full audit
To verify effective correction and corrective actions
INTRODUCTION TO AUDITING
• 12. Short-notice Audits
To investigate complaints
In response to changes
As follow up on suspended clients
INTRODUCTION TO AUDITING
• 14. Audit Trails
INTRODUCTION TO AUDITING
• 15. Auditing statutory and regulatory
requirements
The statutory and regulatory requirements
Auditors need to be aware
Updating all applicable statutory and regulatory
requirements
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Accreditation
Process IAW
AS 9101 F:2016
and AS 9104/1 for
CB(CRB) provide
certification for
AS 9100
AS 9110
AS 9120
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Certification Process
Three steps to complete
Application
Document Review
& Contract
Agreements
Audit and
Certification
ACCREDITATION AND CERTIFICATION
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ACCREDITATION AND CERTIFICATION
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a. Customer Focus
b. Leadership
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• c. Engagement of People
• d. Process Approach
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• e. Improvement
• g. Relationship Management
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2. Process Approach
The process approach involves the systematic definition and
management of processes, and their interactions, so as to
achieve the intended results in accordance with the quality
policy and strategic direction of the organization.
a. General
b. What is the process approach?
c. Risk-based thinking, PDCA and the process approach
d. What are the possible benefits?
e. The process approach in ISO 9001:2015
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AS 9100 D - TERMINOLOGIES
• Counterfeit Part
– An unauthorized copy, imitation, substitute, or modified part (e.g., material, part,
component), which is knowingly misrepresented as a specified genuine part of an
original or authorized manufacturer. Examples of a counterfeit part can include,
but are not limited to, the false identification of marking or labeling, grade, serial
number, date code, documentation, or performance characteristics.
• Critical Items
– Those items (e.g., functions, parts, software, characteristics, processes) having
significant effect on the provision and use of the products and services; including
safety, performance, form, fit, function, producibility, service life, etc.; that
require specific actions to ensure they are adequately managed. Examples of
critical items include safety critical items, fracture critical items, mission critical
items, key characteristics, etc.
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AS 9100 D - TERMINOLOGIES
• Product Safety
– The state in which a product is able to perform to its designed or
intended purpose without causing unacceptable risk of harm to
persons or damage to property.
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LEADERSHIP
1. Leadership and Commitment
• effectiveness of the QMS
• Ensuring that the quality
• policy and quality objectives
• 2. Auditing Guidance – Top Management
• Evidence of top management’s
• awareness of and commitment
• to quality and organization’s objectives
• and management system.
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LEADERSHIP
3. Customer Focus
• Customer and applicable statutory and regulatory requirements are determined.
• The risks and opportunities that can affect conformity of products and services.
• Focus on enhancing customer satisfaction.
• Product and service conformity and on-time delivery performance are measured
and appropriate action is taken if planned results are not, or will not be,
achieved.
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LEADERSHIP
4. Developing the quality policy
• Is appropriate to the purpose and context of the organization.
• Provides a framework for setting quality objectives.
• Includes a commitment
• Satisfy applicable requirements
• Continual improvement of the QMS
• Communicating the quality policy
• Be available and be maintained as documented information.
• Be communicated, understood and applied within the organization
• Be available to relevant interested parties.
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LEADERSHIP
5. Auditing Guidance – Quality Policy
• Audit methods should include:
• Interviewing top management
• Evaluating, through the records of management review.
• Has effectively “translated” the quality policy into the
local languages.
• Conducting interviews with personnel
• Seeking evidence of effective distribution of the quality
policy.
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LEADERSHIP
6. Organizational roles, responsibilities and
authorities
• Ensuring
– Requirements of this international standard
– Delivering their intended outputs
– Promotion of customer focus
– Integrity of the QMS is maintained.
– Reporting on the performance of the QMS
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LEADERSHIP
Top management shall appoint a specific member of the organization’s
management, identified as the management representative, who shall have the
responsibility and authority for oversight of the above requirements.
• d. Risk Management
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Process Objectives
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RISK MANAGEMENT
5. Planning
• Actions to address risk and opportunities
RISK BASED THINKING & PLANNING
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5. Planning
• Actions to address risk and opportunities
• The organization shall plan:
• actions to address these risks and opportunities
• how to
integrate and implement the actions into its
QMS processes (see 4.4)
evaluate the effectiveness of these actions.
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SUPPORT
1. Resources
2. People
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SUPPORT
3. Infrastructure
SUPPORT
5. Monitoring and measuring resources
• a. General
• b. Measurement Traceability
SUPPORT
7. Organizational Knowledge
8. Competence
SUPPORT
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9. Awareness
SUPPORT
11. Communication
SUPPORT
13. Documented Information
• General
• Creating and Updating
• Control of documented information
OPERATION
1. Operational planning and control
a. Operational Risk Management
b. Configuration Management
c. Product Safety
OPERATION
2. Requirements for products and services
a. Customer communication
b. Determining the requirements related to products and services
c. Review of requirements related to products and services
d. Changes to requirements for products and services
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OPERATION
3. Auditing Guidance – Customer communication
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OPERATION
4. Design and Development of Products and Services
a. Design and Development Planning
b. Design and Development Inputs
c. Design and Development Controls
Design and Development Review
Design and Development Verification
Design and Development Validation
• d. Design and Development Outputs
e. Control of Design and Development Changes
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OPERATION
5. Auditing Guidance – Design and Development
a. Auditing the need for design and development
b. Auditing design and development planning
c. Auditing design and development inputs
d. Auditing the design and development controls
e. Auditing design and development outputs
f. Auditing design and development changes
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OPERATION
6. Control of externally provided processes, products and
services
OPERATION
10. Control of nonconforming outputs
a. Controlling Nonconforming outputs by one or more of the
following ways:
correction
segregation, containment, return or suspension of
provision of products and services
informing the customer
obtaining authorization for acceptance under
concession
b. The organization shall retain documented information
that:
describes the nonconformity;
describes the actions taken;
describes any concessions obtained;
identifies the authority deciding the action in respect
of the nonconformity.
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a. General
b. Customer satisfaction
• c. Analysis and evaluation
2. Internal Audit
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• 4. Improvement
a. General
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6. Continual improvement
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organizational objectives
risks and opportunities associated with the audit programme (see 5.3) and the actions to
address them
scope (extent, boundaries, locations) of each audit within the audit programme
AUDITOR RESPONSIBILITIES
1. The Roles and Responsibility of the Team Leader
AUDITOR RESPONSIBILITIES
• 2. The Role of the Auditor
• The auditor is responsible to the Lead Auditor for an allocated segment of the audit programme. This includes:
• Documenting observations
• Recording evidence
AUDITOR RESPONSIBILITIES
3. The Role of the Auditee and Audit Client
• Auditee: Organization being audited
• Audit Client: Organization requesting the audit.
AUDITOR RESPONSIBILITIES
4. Roles & Responsibilities of Guides & Observers
AUDITOR RESPONSIBILITIES
7. Audit Principles
AUDITOR RESPONSIBILITIES
8. IAQG Code of Conduct
It is a condition of certification that you agree to act in accordance
with, and be bound by the following IAQG Code of Conduct:
1. To act in a strictly trustworthy and unbiased manner in relation
to both the organisation to which you are employed, contracted
or otherwise formally engaged (the audit organization) and any
other organisation involved in an audit performed by you or by
personnel under your direct control.
2. To disclose to your employer any relationships you may have
with the organisation to be audited before undertaking any audit
function in respect of that organization.
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1. Pre-Audit Activities
2. On-site Audit Activities
3. Post Audit Activities
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1. Initiating audit
2. Establishing contact with auditee
3. Determining feasibility of audit
PERFORMING AN AUDIT – PRE AUDIT ACTIVITIES Page 145 of 204
Statistical sampling
Preparing audit work documents
When preparing audit work documents, the audit team should consider
the questions below for each document.
Which audit record will be created by using this work document?
Which audit activity is linked to this particular work document?
Who will be the user of this work document?
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Audit Evidence
Audit Findings
Reviewing
Audit Conclusions
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AUDIT FINDINGS
1. Determining Audit Findings
2. Recording conformities
3. Recording nonconformities
4. Dealing with findings related to multiple criteria
AUDIT FINDINGS
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a. Minor Nonconformity
b. Major Nonconformity
AUDIT FINDINGS
AUDIT FINDINGS
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AUDIT FINDINGS
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AUDIT FINDINGS
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1. Closing Meeting
review the audit findings and any other appropriate
information collected during the audit, against the audit
objectives
agree on the audit conclusions, taking into account the
uncertainty inherent in the audit process
prepare recommendations, if specified by the audit plan
discuss audit follow-up, as applicable
AUDIT CONCLUSIONS AND CLOSING MEETING
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Updated PEM Assessment Levels the planned results but appropriate action is
being taken.
3&4
Thank you
We hope you enjoyed your course